BridgeMD
A Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Choroidal Neovascularization Secondary to Pathologic Myopia
EU CTIS ID: 2023-506707-25-00
What this study is testing
1. To evaluate the efficacy of intravitreal (IVT) injections of faricimab compared with ranibizumab
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests
- 2. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia
- 3. Diagnosis of active myopic CNV in the study eye confirmed by ocular examination and CRC review
- 4. BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and assessed at the initial testing distance of 4 meters (see the BCVA manual for additional details) on Day 1
- 5. Presence of at least 1 of the following lesion types (determined by CRC): Subfoveal (presence of abnormal neovasculature in the avascular central fovea) Juxtafoveal (presence of abnormal neovasculature not under the center of the fovea but ≤ 200 um from the center) with involvement of the central macular area Extrafoveal (presence of abnormal neovasculature > 200 um from the center of the fovea) with involvement of the central macular area Margin of the optic disc (presence of abnormal neovasculature at peripapillary area) with involvement of the central macular area
- 6. Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
You likely can't join if
- 1. CNV due to causes other than pathologic myopia, such as neovascular age-related macular degeneration, ocular histoplasmosis, trauma, angioid streaks, choroidal rupture, or uveitis, etc
- 2. Any history of macular pathology unrelated to pathologic myopia affecting vision or contributing to the presence of intraretinal or subretinal fluid
- 3. Presence at screening of central serous chorioretinopathy or myopic tractional maculopathy. Retinal pigment epithelial tear involving the macula on Day 1
- 4. Non-functioning non-study eye, defined as either: BCVA Snellen equivalent of 20/200 or worse No physical presence of non-study eye (i.e., monocular)
- 5. Prior IVT administration of faricimab in either eye
- 6. History of idiopathic or autoimmune-associated uveitis in either eye. Active ocular inflammation (anterior, intermediate or posterior uveitis, grade trace or above) or suspected or active ocular or periocular infection in either eye on Day 1
The study team makes the final eligibility decision.
Where it's taking place
- Singapore
- China
- Taiwan
- Hong Kong
- Korea, Republic of
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore; China; Taiwan; Hong Kong; Korea, Republic of; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.